Transcranial Direct Current Stimulation (tDCS) as an add-on Therapy for Treatment of Major Depressive Disorder. (DEPTDCS2014)

Phase 2

• Conditions: Depression
• Interventions: Device: Sooma tDCS; Device: Sham tDCS

• Registration Number: NCT02521883
• Lead Sponsor: Turku University Hospital

Brief Summary

The aim is to investigate the safety and effectiveness of transcranial Direct Current Stimulation (tDCS) in patients with moderate to severe major depression compared to patients treated with conventional therapy. The tDCS will be used as add-on to conventional therapy.

This is a randomized 2-arm parallel, double blind study comparing 2 groups of 60 patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-08-11
• Study First Submitted QC: 2015-08-11
• Study First Posted: 2015-08-13
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-11
• Last Update Posted: 2018-09-12
• Primary Completion: 2019-12
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Fulfils the ICD-10 diagnostic criteria for moderate or severe major depressive episode (F32), or recurrent major depressive episode (F33)
• Able to understand the purpose and potential risks of the study
• Able to sign informed consent

Exclusion Criteria

• intracranial metal implants or other foreign intracranial metal object
• history of neurological conditions e.g. epilepsy, stroke (ischemic or haemorrhagic); brain tumor; increased intracranial pressure etc.
• schizophrenia
• bipolar disorder
• psychotic disorder
• substance abuse or dependency
• contra-indications to tDCS
• personality disorder that may prevent him/her to commit to the study
• skin lesion in the area of stimulation
• planned treatment of current depressive episode with ECT or rTMS

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Device: Sooma tDCS	Sooma tDCS	The active group will receive active Sooma tDCS treatment for the first three weeks followed by maintenance treatments at weeks 5 and 6.
Device: Sham tDCS	Sham tDCS	The placebo group will receive sham tDCS treatment for the first three weeks followed by sham maintenance treatments at weeks 5 and 6.

Primary Outcome Measures

Name	Time	Method
Change from baseline in Montgomery-Åsberg depression scale (MADRS)	baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months	Efficacy

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Beck Depression Inventory (BDI) scale.	baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months
Dichotomised response measured with MADRS.	baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months	Response to treatment is defined as a ≥ 50% reduction in the MADRS baseline score.
Dichotomised remission measured with MADRS.	baseline, wk 2, wk 4, wk 5, wk 6, 3 months, 6 months	Remission is defined as a MADRS score ≤ 10.

Trial Locations

Locations (4)

PHSOTEY, Psykiatrian tulosalue, ECT-yksikkö; 🇫🇮 Lahti, Finland

VSSHP Psykiatria, Liedon aikuispsykiatrian poliklinikka; 🇫🇮 Lieto, Finland

Sektionen för affektiva sjukdomar, Norra Stockholms Psykiatri, Stockholms läns sjukvårdsområde; 🇸🇪 Stockholm, Stockholms Län, Sweden

Turku University Hospital; 🇫🇮 Turku, Finland